Rationale and design of a three-arm randomized clinical trial to improve drug use and retention in care of people with opioid use disorder on buprenorphine: OVERCOME II study.

Medications for opioid use disorder (MOUD) are effective in reducing opioid use, but retention to buprenorphine remains suboptimal among OUD patients. Integration of computer-based cognitive behavioral therapy (CBT4CBT) and utilization of recovery coaches (RCs), called RC + CBT4CBT-Buprenorphine, into OUD care could improve drug use and retention in care among patients taking buprenorphine. The OVERCOME II (OUD Intervention Recovery Coach CBT and OUD Medications II) study is a three-arm 1:1:1 randomized clinical trial designed to test the remotely delivered RC + CBT4CBT-Buprenorphineintervention as an adjunct to buprenorphine treatment for patients with OUD, and to compare it with both CBT4CBT-Buprenorphine alone and the treatment as usual (TAU). Patients (n = 90) who have newly initiated buprenorphine in the past 90 days are planned to be recruited. Comprehensive measures on demographics, various conditions/constructs, and outcomes will be collected from medical charts and survey instruments. Additionally, neurophysiological outcomes and neurocognitive inhibitory controls will be measured using the NEXUS-10-MKII physiological system with BioTrace+ software and computerized Drug Go/NoGo Task, respectively. Qualitative analysis of interviews with N = 2 RCs and N = 15 participants will also be conducted. The study will be the first to examine the effectiveness of the remotely delivered RC + CBT4CBT-Buprenorphine intervention on drug use (during the first 8 weeks and follow-up) and retention in care, as well as on various neurophysiological and cognitive performances in comparison to CBT4CBT-Buprenorphine alone and TAU. Clinical Trial Registration: This study was registered at ClinicalTrials.gov (NCT06102200, www.clinicaltrials.gov/) on August 31, 2023, with a title, An Integrated Intervention Involving Recovery Coaching and Cognitive Behavioral Therapy for Opioid Use Disorder (OVERCOME 2).